Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Evaluation of Tiotropium 5 µg/Day Delivered Via the Respimat® Inhaler Over 48 Weeks in Patients With Severe Persistent Asthma on Top of Usual Care
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00772538
  Purpose

The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma.

The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.


Condition Intervention Phase
Asthma
Drug: tiotropium
Phase III

MedlinePlus related topics: Asthma
Drug Information available for: Tiotropium Tiotropium bromide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase III Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 Mcg/Day) Over 48 Weeks as Add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Pulmonary function testing after a treatment period of 24 weeks. Time to first severe asthma exacerbation during 48 weeks in pooled analysis of both twin trials [ Time Frame: 24 and 48 weeks ]

Secondary Outcome Measures:
  • Standard spirometric parameters. PEF. Asthma exacerbations, quality of life, asthma control, rescue medication use. Pharmacokinetics, pharmacogenomics, health economics . Adverse events, vital signs, physical examination, vital status observation [ Time Frame: 24, 48 weeks and all time points. ]

Estimated Enrollment: 316
Study Start Date: October 2008
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test at Visit 1).
  2. Male or female patients aged at least 18 years but not more than 75 years.
  3. All patients must have at least a 5-year history of asthma at the time of enrolment into the trial and the diagnosis of asthma must have been made before the patient´s age of 40.
  4. All patients must have a diagnosis of severe persistent asthma and must be symptomatic despite treatment with high, stable doses of inhaled corticosteroids and a long-acting beta adrenergic agent
  5. All patients must have a history of one or more asthma exacerbation in the past year.
  6. Patients must have evidence of treated, severe, persistent asthma in postbronchodilatory pulmonary function tests.
  7. Patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years
  8. Patients must be able to use the Respimat® inhaler correctly
  9. Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the electronic diary/peak flow meter.

Exclusion Criteria:

  1. Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient´s ability to participate in the trial.
  2. Patients with clinically relevant abnormal screening haematology or blood chemistry.
  3. Patients with a recent history (i.e. six months or less) of myocardial infarction, hospitalisation for cardiac failure during the past year, any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year, known active tuberculosis, malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (treated basal cell carcinoma allowed), lung diseases other than asthma (e.g. COPD), significant alcohol or drug abuse within the past two years, patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
  4. Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
  5. Patients using oral corticosteroid medication at stable doses exceeding 5 mg prednisolone or prednisolone equivalent every day or 10 mg prednisolone or prednisolone equivalent every second day.
  6. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution.
  7. Pregnant or nursing women or women of childbearing potential not using a highly effective method of birth control. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy, or post-menopausal for at least two years.
  8. Patients who have taken an investigational drug within four weeks or six half-lives (whichever is greater) prior to Visit 1.
  9. Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®), beta-blocker medication, oral beta-adrenergics, other non-approved and according to international guidelines not recommended ´experimental´ drugs for routine asthma therapy (e.g. TNF-alpha blockers, methotrexate, cyclosporin) within four weeks prior to the Screening Visit (Visit 1) or during the screening period.
  10. Patients with any asthma exacerbation or respiratory tract infection in the four weeks prior to the trial.
  11. Patients who have previously been randomised in this trial or in the respective twin trial (205.416 versus 205.417) or are currently participating in another trial.
  12. Patients with a known narrow-angle glaucoma.

Note:

As with other anticholinergic drugs, tiotropium should be used with caution in patients with prostatic hyperplasia or bladder neck obstruction.

As with all predominantly renally excreted drugs, patients with moderate to severe renal impairment (known creatinine clearance of <= 50 mL/min) treated with tiotropium should be monitored closely.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772538

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

  Show 31 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 205.416, EudraCT no. 2008-001413-14
Study First Received: October 13, 2008
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00772538  
Health Authority: Australia: Responsilble Ethics Committee;   Canada: Therapeutic Products Directorate;   Denmark: The Danish Medicines Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Great Britain: MHRA;   Italy: Comitato Etico per la Sperimentazione Clinica dei Medicinali dell'A.O. Univ. Pisana di Pisa;   Netherlands: Central Committee on Research Involving Human Subjects (CCMO);   Russia: Ministry of Health Care and Social Progress of Russian Federation;   Serbia / Yugoslavia: Medicines and Medical Devices Agency of Serbia, 11152 Belgrade;   South Africa: Medicines Control Council;   Turkey: Ministry of Health Central Ethics Committee;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine);   United States: Food and Drug Administration

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Tiotropium
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory System Agents
Parasympatholytics
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cholinergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009